Flexible acl instrumentation, kit and method

ABSTRACT

In a first embodiment, the present invention includes an instrument for use in preparing a femur for soft tissue repair or reconstruction, including a cannulated, curved guide tool having a cannulated body extending to a distal tip and a plane defined by a longitudinal axis of the cannulated body and distal tip; and a flange secured to the distal tip and extending from the distal tip in a direction transverse from the distal tip, the flange having a first curve along at least a portion of the flange and a degree of tilt, relative to the plane, along at least a portion of the flange. In an alternate embodiment, the present invention may also include a method of preparing a bone for reattachment of soft tissue thereto, including visualizing a reattachment site; selecting a guide tool from a plurality of cannulated curved guide tools, each of the plurality of guide tools having a distal tip that includes a flange; directing the distal tip of the selected guide tool towards the reattachment site; and placing the flange against the surrounding anatomy such that the distal tip is on the reattachment site.

BACKGROUND OF THE INVENTION

The present invention relates generally to instrumentation, kits andmethods for reconstruction of soft tissue, including soft tissue such astendons and ligaments, and particularly the anterior cruciate ligament(ACL) and posterior cruciate ligament (PCL) in the knee joint.

ACL injuries are often caused by a sudden force applied to the knee, andare a common form of injury in athletic activities. The injury occurstypically when the knee is bent or twisted in an awkward direction.

Current surgical reconstruction of ACL injuries may be arthroscopic oropen and commonly include the formation of two bone tunnels, one in thetibia and one in the femur, which serve as attachment points for a softtissue graft. Procedures for formation of the bone tunnels typicallyfall into two main categories. The first commonly uses a “trans-tibial”procedure in which a linear offset guide is placed through a tunneldrilled in the tibia. The offset guide positions a rigid guide pin, alsopositioned through the tibial tunnel, towards the femur to form thefemoral tunnel. However, this procedure often does not allow the surgeonto position the guide pin at the correct anatomical site of the nativeACL (the native ACL attachment point) on the femur. As a result, therotational stability of the ACL replacement graft is reduced.

The second type of common surgical reconstruction uses an“anterior-medial portal” procedure in which a similar offset guide isplaced through a skin incision and into the joint. Since the guide isnot within the tibial tunnel in this approach, the guide is less stablebut has the freedom to be placed anywhere along the femoral notch,though accessing the native ACL attachment point with the rigid guidepin is normally not possible without hyperflexion of the knee. Thus,without hyperflexion of the knee during rigid pin placement, the lengthof the femoral tunnel could be shorter than usually desired in additionto other pitfalls such as pin proximity to, for example, the peronealnerve and the femoral insertion point of the Lateral CollateralLigament. However, hyperflexion has various drawbacks: the surgeon losesthe visual reference to anatomic landmarks that are usually seen at anormal, ninety degree, flexion, and hyperflexion is difficult to do whenusing a leg holder, which is typically used in all repair/reconstructionprocedures, or may be impossible due to a patient's build or anatomy.The surgeon can compromise tunnel integrity and thus fixation strengthif the joint is not hyperflexed properly. However, if done properly, thenative ACL attachment point may be accessed in order to position the ACLgraft at or near this native point.

During such arthroscopic surgical procedures, particularly on a joint,such as a knee, a surgeon will force a clear liquid, such as saline orRinger solution, into the joint to provide better viewing potentialthrough an arthroscopic camera. The clear liquid forces blood and otherfluids, suspended solids and debris from the joint. In order to maintainthe joint volume free of these other substances, the clear liquid mustbe maintained at an elevated pressure, otherwise viewing ability islost.

Typically in arthroscopic procedures, a surgeon will use a cannula, orthe like, which provides an entryway for surgical tools into the joint,as well as, detrimentally, an exit for the clear liquid from the joint.Furthermore, cannulated guide tools may be passed into the joint via acannula or directly through surgical incisions without a cannula. Suchcannulated tools also provide a conduit for the clear liquid to exit thejoint. When such instruments are used, the surgeon must increase theflow of clear fluid into the joint, using a fluid pump for example, tomaintain the required elevated pressure. And in some instances, such alarge amount of clear fluid is lost through the cannula or cannulatedguide tool that maintaining the elevated pressure is not feasible.Moreover, the clear fluid may exit onto the surgeon's hands and even thefloor, leading to dangerous safety conditions such as a slippery floorwhere the surgeon is working.

Thus, there is a need in ligament and tendon repair or reconstructionsurgery for instrumentation and procedures which may be used, forexample, for ACL surgery with the knee at various normal degrees offlexion, including ninety degree flexion and even at hyperflexion, ifneeded, which may be capable of aligning the drill pin to contact thefemur at the native ACL attachment site, which may be simple andreplicable, which may be used in arthroscopic procedures in which aclear liquid is used within the surgical space, and which has otherbenefits over the existing instrumentation and procedures.

BRIEF SUMMARY OF THE INVENTION

In a first embodiment, the present invention may include an instrumentfor use in preparing a femur for soft tissue repair or reconstruction,including a cannulated, curved guide tool having a cannulated bodyextending to a distal tip and a plane defined by a longitudinal axis ofthe cannulated body and distal tip; and a flange secured to the distaltip and extending from the distal tip in a direction transverse from thedistal tip, the flange having a first curve along at least a portion ofthe flange and a degree of tilt, relative to the plane, along at least aportion of the flange. The first curve may further be in at least afirst direction. The flange may further include a second curve in atleast a second direction, different from the first direction, along atleast a portion of the flange. The first and second curves may bepositioned along the flange, or alternatively, the first and secondcurves may extend along substantially the same portion of the flange oralong different portions of the flange. The first curve may have anangle between about 0 degrees and about 90 degrees, and the second curvemay have an angle between about 0 degrees and about 30 degrees. Thedegree of tilt may further be an angle of between about 0 degrees andabout 90 degrees, or alternatively the degree of tilt may be about 45degrees. Furthermore, the flange may be offset to one side of the plane.The complex three-dimensional shape may substantially mimic the anatomyof a femur (such as, for example, an edge of a condyle on the distalfemur) such that the flange may be adapted to engage the anatomy along asubstantial portion of the flange, or even along substantially theentire length of the flange. Further, the cannulated, curved guide toolmay be adapted to accept a flexible drill pin through the cannulatedbody, wherein the flexible guide pin may exit out the distal tip andinto bone. The flange may extend in a direction transverse to theflexible drill pin exiting from the distal tip of the cannulated body.

In another embodiment, the present invention may include a method ofpreparing a bone for reattachment of soft tissue thereto, includingvisualizing a reattachment site selecting a guide tool from a pluralityof cannulated curved guide tools, each of the plurality of guide toolshaving a distal tip that includes a flange; directing the distal tip ofthe selected guide tool towards the reattachment site; and placing theflange against the surrounding anatomy such that the distal tip is onthe reattachment site. The flange may further have a complexthree-dimensional surface which substantially mimics the surroundinganatomy. The cannulated curved guide tools may include a cannulated bodyextending to the distal tip. Furthermore, the method may includeinserting a flexible drill pin through the cannulated body such that itexits from the distal tip and projects into the reattachment site on thebone. The method may be performed arthroscopically.

In a further embodiment, the present invention may include a method ofpreparing a bone for ACL reconstruction, including drilling a tibialtunnel; forming a portal through skin adjacent a knee joint; selectingfrom a plurality of cannulated curved guide tools; passing a distal endof the curved guide through the portal and into the knee joint; placingthe distal end of the curved guide against the femur; attaching afilament to a proximal end of the flexible pin; drilling a flexible pinthrough the curved guide and into the femur; once the pin is positionedwithin a joint space, grasping the suture through the tibial tunnel andpulling the pin backwards into the tibial tunnel; inserting a flexiblereamer over the proximal end of the pin; inserting the reamer into thetibial tunnel and into the joint space; and reaming a femoral tunnelalong the pin.

In yet a further embodiment, the present invention may include a methodof creating a tibial tunnel for PCL reconstruction including forming aposterior portal through the skin adjacent a knee joint; selecting froma plurality of cannulated curved guide tools and placing the curvedguide adjacent a PCL insertion site on a posterior aspect of the tibia;drilling a flexible pin through the flexible guide and into the tibia.The method may further include removing the cannulated curved guide andinserting a flexible reamer over a proximal end of the flexible pin toream a tibial tunnel. The method may alternatively include inserting aflexible reamer over a distal end of the flexible pin and reaming atibial tunnel from an anterior surface of the tibia and rearwards to theposterior aspect of the tibia.

The present invention may generally, in a further embodiment, includeinstrumentation for preparing the tibia and femur for ACLreconstruction. The instrumentation may include any of a flexible pin, afemoral aimer, a curved guide tool and a flexible reamer. The use ofthese instruments may create tunnels through the tibia and femur forattachment of a graft (whether natural or artificial) which may serve asa replacement ACL. The instrumentation may further include otherelements such as a power drill (for connection with at least one of theflexible pin and flexible reamer) and a starter awl (for forming a pilotdivot at the insertion point on the tibia and/or femur).

In one embodiment, the present invention may include an instrumentationsystem for preparing a bone for soft tissue reconstruction, theinstrumentation system may include a flexible drill pin capable ofbending along a curved path; an aimer capable of engaging the flexiblepin to bend the flexible pin; and a flexible reamer having a flexibleportion along at least a portion of its length, the flexible portioncomprising a plurality of laser cuts.

The flexible drill pin may be composed of Nitinol, and may furtherinclude a distal portion and a proximal portion, wherein the distalportion includes a trocar tip and the proximal portion includes a sutureconnection. The aimer may further at least substantially surround acircumference of the flexible drill pin. The flexible portion of theflexible reamer may further include discrete, interlocking portions, andmay also be cannulated along at least a portion of its length forplacement of the flexible reamer over the flexible pin. The flexibleportion may also be cannulated along at least a portion of its lengthfor placement over at least the bent portion of the flexible pin. Theflexible reamer may further include an asymmetric tip having at leastone prominent cutting edge positioned off-axis relative to alongitudinal axis of the flexible reamer. The tip may further include atleast one cutting edge which is comparably less prominent.

The instrumentation system may further include additionalinstrumentation such as a starter awl, suture and other instruments usedin arthroscopic orthopedic surgery. The system may be used on a femurand an ACL, wherein the instrumentation system forms a tunnel in thefemur extending from the knee joint.

In an alternate embodiment, the present invention may be a method forpreparing a bone tunnel in a femur adjacent a knee joint, the method mayinclude introducing a flexible drill pin into the knee joint; guidingthe flexible drill pin towards a surface of the femur with an instrumentintroduced into the knee joint; drilling the flexible drill pin into thefemur; removing the instrument from the knee joint; introducing acannulated flexible reamer into the knee joint by placing the flexiblepin within the cannulation of the flexible reamer; and reaming the bonetunnel in the femur along the path of the flexible pin.

The method may further include the step of the instrument guiding theflexible pin along a curved path towards the surface of the femur. Theflexible drill pin may further be drilled through the femur and may exitout a lateral side of the femur. Additionally, the flexible drill pinmay follow a curved path from introduction in the knee joint to thesurface of the femur, and may follow a generally straight andsubstantially linear path from the surface of the femur, through thefemur, and out the lateral side of the femur. The instrument may be afemoral aimer or a curved guide tool. The flexible reamer may furtherinclude a flexible portion along at least a portion of a length of theflexible reamer, the flexible portion comprising a plurality of lasercuts. The flexible portion of the flexible reamer may further includediscrete, interlocking portions.

In this method, the flexible drill pin, instrument, and flexible reamermay also be introduced into the knee joint through an at least oneportal. Alternatively, the flexible drill pin and flexible reamer may beintroduced into the knee joint through a bone tunnel through a tibia,and the instrument may be introduced into the knee joint through aportal.

In another embodiment, the present invention may include instrumentationfor preparing bone tunnels which may include a flexible pin, a femoralaimer, and a flexible reamer. A first embodiment of a flexible reamermay include a tip having at least one prominent cutting edge wherein theprominence of the edge is asymmetric compared to the shaft of the reameror other cutting edges.

The present invention may also include various additional embodimentsfor methods of use of the instrumentation for bone tunnel preparationfor ACL reconstruction. These embodiments may be used when the knee ispositioned at a “normal” flexion, for example, at ninety degrees, and aknee holder (as is known in the art) may also be used, if needed.Typically, the flexible pin is passed through the tibia and then throughthe knee joint and into the femur. An anterior-medial portal may also beformed, through which the femoral aimer passes through the skin and intothe joint. The femoral aimer interacts with the flexible pin, as the pinpasses through the joint, and may guide the pin to the proper locationon the femur. In one example, the femoral aimer adjusts the trajectoryof the pin such that the pin follows a curved path from the tibia to thefemur.

A further embodiment of the methods of the present invention may includea method for preparing bone tunnels including the steps of placing aflexible pin through one of a portal or a bone tunnel, placing an aimerthrough the portal, contacting a distal portion of the pin with theaimer to alter the trajectory of the pin towards a desired position,pushing the pin through bone, placing a flexible reamer onto the pin andmoving the reamer along the pin to create a second tunnel.

In one embodiment, the method of ACL reconstruction may include forminga tibial tunnel in a knee joint, forming an anterior-medial portal inthe knee joint, placing a flexible pin through the tibial tunnel andinto the knee joint, placing a femoral aimer through the anterior-medialportal, contacting a distal portion of the pin with the aimer to alterthe trajectory of the pin towards a position on the femur, drilling thepin through the femur, placing a flexible reamer onto the pin and movingthe reamer along the pin passing through the tibial tunnel and reaming afemoral tunnel along a portion of the length of the pin within thefemur, removing the reamer, connecting a suture and graft to a sutureconnector on a proximal end of the pin, pulling the pin proximally topull the graft through the tibial tunnel and into the femoral tunnel,and securing the graft.

In a further embodiment, the method of ACL reconstruction may includeforming a tibial tunnel through a tibia. The tunnel may be directed in aproximal direction through the tibial plateau and may open into the kneejoint. The tunnel may be formed using a drill. The drill may then beremoved from the tibia and a flexible pin may be passed up through thetibia. The pin should be passed through the tibia until a distal portionextends into the knee joint. An anterior-medial portal may also beformed through the skin to allow access into the knee joint. A femoralaimer may be passed through the portal and positioned within the kneejoint. As the distal portion of the pin enters the joint, the femoralaimer may interact with the pin to adjust the trajectory of the pin andguide it towards a desired location on the femur. Optionally, thedesired location on the femur may be marked using a starter awl, orother instrument, to form a pilot divot. Once the pin is placed againstthe femur, the pin may be passed through the femur until it exits thefemur, proximal to the knee joint, and through the adjacent skin. Aflexible reamer (which may, for example, be cannulated) may then bepositioned onto the pin such that the flexible reamer passes through thetibial tunnel and contacts the femur. The reamer may then be used toform a femoral tunnel to a specified depth. Leaving the pin in place,the reamer may then be removed from the femur and tibia. The pin mayhave a suture connector on its proximal portion (i.e., an eyelet or thelike), through which a suture is passed which may contain a graftthereon. The pin is then pulled proximally, from where it exited thefemur, to pull the suture and graft up through the tibial tunnel andinto the femoral tunnel. The graft may then be secured.

In another embodiment, the method may include forming a tibial tunnelthrough the tibia. The tunnel may be directed in a proximal directionthrough the tibial plateau and may open into the knee joint. The tunnelmay be formed using a drill. The drill may then be removed from thetibia and a flexible pin may be passed up through the tibia. The pinshould be passed through the tibia until a distal portion extends intothe knee joint. An anterior-medial portal may also be formed through theskin to allow access into the knee joint. A femoral aimer may be passedthrough the portal and positioned within the knee joint. As the distalportion of the pin enters the joint, the femoral aimer may interact withthe pin to adjust the trajectory of the pin and guide it towards adesired location on the femur. Optionally, the desired location on thefemur may be marked using a starter awl, or other instrument, to form apilot divot. Once the pin is placed against the femur, the pin may bepassed through the femur until it exits the femur, proximal to the kneejoint, and through the adjacent skin. The pin may have a sutureconnector on its proximal portion (i.e., an eyelet or the like), throughwhich a suture is passed. The pin is then pulled proximally, from whereit exited the femur, to pull the suture up through the tibial tunnel andinto the joint space. The suture and/or proximal portion of the pin maybe grasped by an instrument through the anterior-medial portal, and thepin may then be pulled backwards through the portal. A flexible reamer(which may, for example, be cannulated) may then be positioned onto thepin such that the flexible reamer passes through the portal and contactsthe femur. The reamer may then be used to form a femoral tunnel to aspecified depth. Leaving the pin in place, the reamer may then beremoved from the femur and the portal. A suture may be attached to theproximal portion of the pin. The pin may then be pulled, from its distalend, back up through the femoral tunnel, until the proximal end of thepin is visible within the knee joint. The pin may then be moved distallyback through the tibial tunnel utilizing the suture or the sutureconnector, such that the suture and suture connector are outside thetibia. A suture, containing a graft, may be placed on the sutureconnector. The pin is then pulled proximally, from where it exits thefemur, to pull the suture and graft up through the tibial tunnel andinto the femoral tunnel. The graft may then be secured.

In yet another embodiment, the method may include passing a flexible pinthrough the tibia. The pin may be directed in a proximal directionthrough the tibial plateau and into the knee joint. An anterior-medialportal may also be formed through the skin to allow access into the kneejoint. A femoral aimer may be passed through the portal and positionedwithin the knee joint. As the distal portion of the pin enters thejoint, the femoral aimer may interact with the pin to adjust thetrajectory of the pin and guide it towards a desired location on thefemur. Optionally, the desired location on the femur may be marked usinga starter awl, or other instrument, to form a pilot divot. Once the pinis placed against the femur, the pin may be passed through the femuruntil it exits the femur, proximal to the knee joint, and through theadjacent skin. A flexible reamer (which may, for example, be cannulated)may then be positioned onto the pin such that the flexible reamer drillsthrough the tibia and the femur in a single continuous motion to form atibial tunnel and a femoral tunnel. The reamer may form a femoral tunnelto a specified depth. Leaving the pin in place, the reamer may then beremoved from the femur and tibia. The pin may have a suture connector onits proximal portion (i.e., an eyelet or the like), through which asuture is passed which may contain a graft thereon. The pin is thenpulled proximally, from where it exited the femur, to pull the sutureand graft up through the tibial tunnel and into the femoral tunnel. Thegraft may then be secured.

In another embodiment, the method may include forming a tibial tunnelthrough the tibia. The tunnel may be directed in a proximal directionthrough the tibial plateau and may open into the knee joint. The tunnelmay be formed using a drill with a diameter which is narrower than thediameter of the final tibial tunnel, discussed below. Thenarrow-diameter drill may then be removed from the tibia and a flexiblepin may be passed up through the tibia. The pin should be passed throughthe tibia until a distal portion extends into the knee joint. Ananterior-medial portal may also be formed through the skin to allowaccess into the knee joint. A femoral aimer may be passed through theportal and positioned within the knee joint. As the distal portion ofthe pin enters the joint, the femoral aimer may interact with the pin toadjust the trajectory of the pin and guide it towards a desired locationon the femur. Optionally, the desired location on the femur may bemarked using a starter awl, or other instrument, to form a pilot divot.Once the pin is placed against the femur, the pin may be passed throughthe femur until it exits the femur, proximal to the knee joint, andthrough the adjacent skin. A flexible reamer (which may, for example, becannulated), having a larger diameter than the narrow-diameter drill,may then be positioned onto the pin such that the flexible reamerexpands the diameter of the tibial tunnel and contacts the femur. Thereamer may then be used to form a femoral tunnel to a specified depth.Leaving the pin in place, the reamer may then be removed from the femurand tibia. The pin may have a suture connector on its proximal portion(i.e., an eyelet or the like), through which a suture is passed whichmay contain a graft thereon. The pin is then pulled proximally, fromwhere it exited the femur, to pull the suture and graft up through thetibial tunnel and into the femoral tunnel. The graft may then besecured.

In yet another embodiment, the method may include forming a tunnelthrough the tibia. The tunnel may be directed in a proximal directionthrough the tibial plateau and may open into the knee joint. Ananterior-medial portal may also be formed through the skin to allowaccess into the knee joint. Using a curved guide tool, advancing aflexible drill pin, having an eyelet on its proximal end, the eyeletholding a suture, through the anterior-medial portal and into a femur.The flexible pin may be drilled to a depth such that the suture may beretrieved through the tibial tunnel. Once the suture is drawn throughthe tibial tunnel, pulling the drill pin backwards and into the tibialtunnel. Once the proximal end of the pin exits the tibial tunnel,advancing a cannulated flexible reamer along the drill pin and into thefemur, to form a femoral tunnel. Such a method may protect cartilagewithin the knee joint from the reamer, for example, the medial condyle.

In yet another embodiment, the instrumentation may include a curvedguide tool which may have a hollow curved guide, a handle, and anoutrigger.

Additionally, the curved guide may have a bone engaging tip.Alternatively, the curved guide may have a flange, which may further beadapted to engage the surrounding anatomy adjacent to or on the bone.

The bone engaging tip may be any one of a single point, positionedanywhere on a distal end of the curved guide, or may include more thanone point, wherein the points are positioned anywhere on the distal endof the curved guide.

The flange may have an offset from a longitudinal axis of the curvedguide and may further have a shape adapted to engage a structure on hardor soft tissue at a surgical site. The offset may further be at anyangle, such as between about 0 degrees and 90 degrees. The flange mayfurther have a second offset, distal to the first offset. The secondoffset may be more than 0 degrees, and more specifically at least 20degrees, and even more particularly about 45 degrees.

Additionally, the outrigger may swivel relative to the handle and curvedguide. The outrigger may also include an extension having a longitudinalaxis along its length. The handle, curved guide, and outrigger may allbe positioned generally along a single plane. The curved guide mayfurther be hollow along its length to allow passage of a pin, guidewire,or the like therethrough, for placement into the bone. In yet anotherembodiment, a curved guide tool may include a curved guide having aflange on a distal end and an outrigger. The flange may further beadapted to substantially mate with a portion of the anatomy at thesurgical site. The outrigger may further be adapted to lay along outertissue, for example, skin, outside of the surgical site but along thesame plane as the curved guide. The curved guide tool may furtherinclude a handle.

The instrumentation may be used within a joint, such as a knee joint.Further, the instrumentation may be used on a femur bone to repair orreconstruct surrounding soft tissue. For example, the instrumentationmay be used for ACL reconstruction, such as attachment of an ACL to thefemur, wherein the ACL is a natural ACL, ACL graft, ACL implant, tendongraft, bone-tendon-bone graft or the like. The instrumentation can alsobe useful for PCL reconstruction, ACL revision surgery, and PCL revisionsurgery.

The present invention also includes various embodiments for methods ofuse of the instrumentation for bone preparation for soft tissue repairor reconstruction, such as ACL reconstruction. In one embodiment, themethod may include forming an anterior-medial portal in soft tissueadjacent a knee joint; inserting a curved guide of a curved guide toolthrough the portal and into the joint; directing a distal tip of thecurved guide towards the surface of a bone; engaging an outrigger withthe outer surface of the skin of the body, the outrigger having alongitudinal axis extending along its length; and passing a pin throughthe curved guide and into the bone, wherein the pin passes through thebone and protrudes through the skin in a direction generally towards theaxis of the outrigger.

The step of directing the distal tip of the curved guide towards thesurface of the bone may further include engaging the bone with thedistal tip of the curved guide wherein the distal tip is pointed. Thisstep may alternatively include engaging anatomy, such as soft tissue,overlying the bone, with the distal tip of the curved guide wherein thedistal tip is a flange. The flange may further be adapted to match theanatomy of the soft tissue. Either of the pointed tip or flangeconfigurations may provide a surgeon with assurance that the curvedguide is in proper placement for the ACL reconstruction.

In yet another embodiment, the curved guide tool having the distal pointmay first be positioned at the surgical site. The distal point may thenbe used as an awl to mark the correct entry point for the pin. Then,this curved guide tool may be removed, and the curved guide tool havingthe flange may next be positioned at the surgical site. The curved guidetool having the flange may then be positioned on the anatomy and the pinpassed through the curved guide into the bone.

The instrumentation may include a cannulated guide tool which may have ahollow guide, a handle, and a plug. The cannulated guide tool mayfurther optionally include an outrigger. The cannulated guide mayfurther be hollow along its length to allow passage of a pin, guidewire,or the like therethrough, for placement into the joint or bone.

In one embodiment, the plug may be a type of one-way valve. The plug mayopen to allow the passage of a pin, or the like, into the joint, but mayclose to prohibit the flow of fluid from the joint and out thecannulated guide. In one arrangement, the plug may include a dam whichmay pivot on an axis between an open position and a closed position. Theplug may further include a manual activation which a surgeon may use tomanually move the dam from an open position to a closed position.

In a further embodiment, the present invention may include a cannulatedguide tool including a cannulated opening, a handle and a plugpositioned within the cannulated opening. The plug may further include adam and a pivot on which the dam rotates from a closed position,substantially blocking the cannulated opening, to an open position,substantially clear of the cannulated opening. The plug may furtherinclude a manual activation to manually pivot the dam between the openand closed positions. The plug may alternatively, in a differentarrangement, include a spring bias to maintain the dam in one of an openor closed position. The plug may further include the dam having atapered portion.

The present invention also includes various embodiments for methods ofuse of the instrumentation for bone preparation for soft tissue repairor reconstruction, such as ACL reconstruction. In one embodiment, themethod may include establishing a supply source of a clear fluid into ajoint, such as a knee; forcing the clear fluid into the knee joint fromthe supply source; forming an anterior-medial portal in soft tissueadjacent the joint; inserting a cannulated guide of a cannulated guidetool through the portal and into the joint, the cannulated guide toolcomprising a plug positioned in a closed position; directing a distaltip of the curved guide towards the surface of a bone; and passing a pinthrough the curved guide and into the bone, wherein the plug is pivotedto an open position upon entry of the pin into the cannulated guide. Themethod may further include removing the pin from the joint andcannulated guide, wherein the plug returns to the closed position.

Other variations of the instrumentation and methods disclosed hereinrelating to soft tissue repair or reconstruction, whether as to ACL orother soft tissues, are also within the scope of this invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-B, illustrated as photographs, illustrate one embodiment of astarter awl.

FIGS. 2-4 illustrate various embodiments of distal tips of flexiblepins, including examples of various dimensions of the pins thereon.

FIGS. 5-8 (FIG. 8 illustrated as a photograph) illustrate variousembodiments of femoral aimers.

FIG. 9 illustrates one embodiment of an active femoral aimer.

FIGS. 10 and 11 illustrate a first embodiment of a curved guide tool ofthe present invention in various configurations.

FIGS. 12-17 illustrate various views of a second embodiment of a curvedguide tool of the present invention in various configurations.

FIGS. 18A-F illustrate various configurations of a distal tip of oneembodiment of a curved guide of the present invention.

FIG. 19 illustrates one configuration of using an embodiment of a curvedguide tool of the present invention.

FIG. 20 illustrates various configurations of a flange on a distalportion of an embodiment of a curved guide of the present invention.

FIGS. 21A-E illustrate additional configurations of a flange on a distalportion of an embodiment of a curved guide of the present invention.

FIG. 22 is a proximal view of one embodiment of a curved guide tool ofthe present invention.

FIG. 23 illustrates one embodiment of a method of using an embodiment ofa curved guide tool of the present invention on a knee joint.

FIG. 24 illustrates an embodiment of a method of using an embodiment ofa curved guide tool of the present invention on a knee joint.

FIG. 25 illustrates an embodiment of a method of using an embodiment ofa curved guide tool of the present invention on a knee joint.

FIG. 26 illustrates a further embodiment of a method of using anembodiment of a curved guide tool of the present invention on a kneejoint.

FIG. 27 illustrates one embodiment of a flange on a distal end of acurved guide adapted to substantially mimic the posterior portion of alateral condyle used during surgery on a knee joint.

FIG. 28 illustrates a further embodiment of a cannulated guide tool ofthe present invention.

FIGS. 29 and 30 illustrate a close-up of a proximal end of thecannulated guide tool of FIG. 28.

FIG. 31 illustrates an exploded view of the cannulated guide tool ofFIG. 28 in which an embodiment of a plug is separated from thecannulated guide tool.

FIG. 32 illustrates one embodiment of a plug of the present invention.

FIGS. 33A-C are cross-sectional views of one embodiment of a cannulatedguide tool illustrating one use of the plug therein.

FIGS. 34A and B (illustrated as a photograph), and 35A-C illustratevarious embodiments of a flexible reamer of the present invention.

FIGS. 36A-C, illustrated at photographs, illustrate one embodiment of amethod of tibial drilling in PCL reconstructive surgery.

FIGS. 37A-E illustrate one embodiment of a method of ACL reconstructivesurgery.

FIGS. 38-41 illustrate a further embodiment of a flange on a distal endof a curved guide adapted to substantially mimic the posterior portionof a lateral condyle used during surgery on a knee joint.

FIGS. 42A-C illustrate the embodiment of the flange shown in use inFIGS. 38-41.

FIGS. 43 and 44 illustrate one embodiment of a curved guide being usedfor PCL reconstructive surgery.

DETAILED DESCRIPTION

While the following instrumentation and surgical methods may be used torepair or reconstruct any suitable type of soft tissue—such as ligamentsand tendons in a knee, hip, ankle, foot, shoulder, elbow, wrist, hand,spine, or any other area of anatomy—arthroscopic repairs orreconstructions of an ACL in a knee joint will be the exemplary focus ofthe disclosure below. In most of the below embodiments, the presentinvention forms a tibial bone tunnel and a femoral bone tunnel, each ofwhich engages one end of an ACL replacement graft. The bone tunnels areintended to be positioned substantially at the location of the nativeACL connection sites, though other locations may be used as desired orrequired based on the specific circumstances of a particular patient.

Other methods and instrumentation for soft tissue, particularly ACL,repair or reconstruction are disclosed in U.S. patent application Ser.No. 12/859,580 filed Aug. 19, 2010, U.S. Provisional Patent ApplicationNo. 61/274,690 filed Aug. 20, 2009, U.S. Provisional Patent ApplicationNo. 61/343,482 filed Apr. 29, 2010, and U.S. Provisional PatentApplication No. 61/358,502 filed Jun. 25, 2010, all owned by the sameentity as this application, the disclosures of which are herebyincorporated herein by reference as if fully set forth herein.

In a first embodiment, the instrumentation system may optionally includea starter awl 5 configured to create a pilot divot on the bone whichwill designate an anatomic insertion point. The awl, as illustrated inFIGS. 1A-B, may form a divot within which a flexible pin, or otherinstrument, may be positioned. In one example, the awl 5 may be used toform a pilot divot on a femur to designate the location of where thefemur tunnel will be positioned.

The instrumentation system may also include a flexible drill pin 10,110, 210, various embodiments of which are illustrated in FIGS. 2-4. Thepin includes a distal portion 12 and a proximal portion (not shown). Thedistal portion 12 includes a sharp tip, such as a trocar tip, and mayfurther include a tapered surface or a “smashed” tip. The proximalportion may include a suture connection such as an eyelet, or the like,for connection of a suture to the pin. FIG. 3 illustrates one embodimentof a simple distal portion of a pin which includes a trocar tip. FIGS. 2and 4 illustrate alternative embodiments which include both a trocar tipand at least one tapered portion. For example, FIG. 2 includes a “neck”within the distal portion 12 which provides for greater flexibilitybecause the neck has a narrower diameter than the rest of the pin—forexample, the neck may have a diameter of about 1.5-2.0 mm, while thetrocar tip and shaft of the pin may have a diameter of about 2.1-2.5 mmand more specifically about 2.4 mm. FIG. 4 illustrates an embodimenthaving a single taper from the larger diameter of the trocar tip (forexample, about 2.4 mm), to the smaller diameter of the shaft (forexample, about 2.2 mm). The pin may also have a slightly smashed orenlarged tip to ensure that after drilling the pin, it is easier tomaneuver the pin within the bone as the length of the pin is of aslightly smaller diameter than this enlarged tip.

The flexible pin 10, 110, 210 may be flexible to allow for bending toform a curved path between, for example, a first and second bone, suchas a tibia and a femur, or through and along a curved path of acannulated instrument. The pin 10, 110, 210 should not be too stiffbecause it could have trouble obtaining the required bend to reach thedesired anatomical location. Likewise, the pin should not be tooflexible as it will have too little strength to penetrate bone and/ordense soft tissue. In one example, the pin 10, 110, 210 may be made ofNitinol which is flexible enough to maintain a bend along at least aportion of its length to the correct anatomical location. Likewise,Nitinol is strong enough to puncture bone and/or soft tissue. Moreover,Nitinol may have shape memory characteristics which allow the pin 10,110, 210 to be “set,” meaning that at a certain temperature, the pin 10,110, 210 can become more or less stiff/flexible. For example, it may bedesired that the pin be more flexible prior to an action such asdrilling (using a power drill connection) to allow for easier placementof the pin to the anatomical location. Once drilling begins, it may bedesirable for the pin to be more rigid to more easily penetrate the boneand/or soft tissue despite the bend in the pin between the two bones, aswell as to drill the bone tunnel along a generally straight andsubstantially linear path (for example, a bend may be present betweenthe bones, but within the bones the tunnels may be generally straight).Therefore, to obtain these desired results in this example, the Nitinolpin is used because Nitinol may have “shape memory” characteristics. Toutilize the shape memory characteristics, the Nitinol flexible pin isdesigned to have a “set temperature” which may be slightly higher thanbody temperature (for example, between 40 and 60 degrees Celcius). Thus,at a lower temperature, below the set temperature, the flexible pin isflexible and can be easily bent from its original, generally straightand substantially linear shape. However, at a higher temperature, abovethe set temperature, the flexible pin becomes less flexible, and furtherif, upon heating, is in a bent position, will tend to return to itsoriginal, generally straight and substantially linear shape. Thus, priorto drilling the flexible pin into the femur, the flexible pin would beat the lower temperature, and can easily bend between the tibia andfemur, or through a curved cannulated guide. But once drilling into thefemur commences, the distal portion of the flexible pin, upon enteringthe femur, will increase in temperature to above the set temperature,which causes this distal portion of the pin to tend to return to itsoriginal generally straight and substantially linear shape, whichresults in a generally straight and substantially linear femoral tunnelpath. If the flexible pin is drilled into the tibia to form a tibialtunnel path, heating would also occur thus causing the pin to form agenerally straight and substantially linear path through the tibia.

The instrumentation system may further include a femoral aimer which mayengage the flexible pin and alter the trajectory of the pin within ajoint. To continue the example of ACL reconstruction, the femoral aimermay be used to bend the pin to have a curved path, which may beextending from the tibia or from a location outside of the joint, to theanatomical location for entry into the femur. Various embodiments offemoral aimers 20, 120, 220 are illustrated in FIGS. 5-8, in which eachof the aimers may substantially surround, or alternatively, completelysurround, a circumference of the flexible pin. FIG. 5 illustrates afunnel-shaped aimer 20 in which the pin is positioned within the funnel,and the funnel is then rotated to bend the pin along a curved path tothe proper anatomical location on the femur. FIGS. 6 and 8 illustrate aside-slot aimer 120 which is able to be easily disengaged from the pinsince it does not completely surround the pin when pin is placed withinthe side slot. In an embodiment where the instrumentation comes as akit, the kit may include both left and right side-slotted aimers 120 foradded diversity of use. A further embodiment of a femoral aimer 220, asillustrated in FIG. 7, may include a forked tip within which the pin maybe positioned.

In yet another embodiment of a femoral aimer, FIG. 9 illustrates an“active” aimer 320. Active aimer 320 may include a moveable tip portionthat can attach and detach itself from the pin using any type ofmechanical movement. Active aimer 320 may, in some embodiments, be ableto completely surround the pin during attachment, which may provideadditional control of the pin during alteration of trajectory, whilealso being able to detach itself from the pin without regard to theactual position of the pin or the pin end portions. FIG. 9, for example,discloses a jaw type aimer which can open and close and which maycompletely surround the pin during use.

In another embodiment, an instrumentation system of the presentinvention may include a guide pin, such as the variations discussedabove, and a curved guide tool 510, as illustrated in FIGS. 10 and 11.Curved guide tool 510 may include a handle 515, curved guide 520 and anoutrigger 550. The curved guide tool 510 is operated by a surgeongrasping handle 515 (see FIG. 19). The curved guide 520 is positionedwithin a throughbore 531 in handle 515, such that a portion 528 of theguide 520 is proximal to the handle 515 and a portion 521 of the guide520 is distal to the handle 515. A setscrew 526 secures guide 520relative to handle 515. Alternatively, setscrew 526 may instead be amovable screw such that the screw may be loosened and the guide 520 canmove in a distal-proximal direction relative to handle 515 or rotate onan axis of a linear portion (generally, 521, 528) of guide 520 relativeto handle 515. The guide 520 includes a curved distal end 522 and mayinclude a pointed distal tip 523. Distal tip 523 may be any arrangementof at least one point which is adapted to engage bone by, for example,digging into bone surface. FIGS. 18A-F illustrate various configurationsof distal tip 523. The guide 520 is hollow, and preferably cannulatedalong its entire length, to provide for the passage of, for example, aflexible drill pin or guide wire, therethrough.

The outrigger 550 includes a swivel connection 554, which may connectoutrigger main body 551 to handle 515. The main body 551 may include anopening 552. Outrigger 550 also includes an extension 553, having alongitudinal axis along its length. As seen in FIGS. 10 and 11, withcurved guide secured to handle 515 through setscrew 526, outrigger 550may swivel at connection 554 at least from the body of the handle 515around to the body of the curved guide 520, where guide 520 may nestwithin opening 552 at a maximum range of outrigger 550 motion towardsguide 520. Outrigger 550, throughout its swivel range, remains along thegeneral plane of the guide tool 510, wherein the plane is definedgenerally along the longitudinal axes of all of handle 515, guide 520,and outrigger 550. Opening 552 in main body 551 also allows outrigger550 to pass over the portion 528 of curved guide 520. In the embodimentof curved guide 520 connected to handle 515 through a movable screw,curved guide 520 should be positioned sufficiently in the distaldirection, relative to handle 515, to shorten the length of portion 528to allow passage through opening 552. The movable screw may be loosenedto adjust the distal-proximal arrangement of curved guide 520 relativeto handle 515. Once outrigger 550 moves over portion 528, surgeon maythen readjust the distal-proximal arrangement of curved guide 520relative to handle 515 as needed.

FIGS. 12-17 illustrate a further embodiment of the curved guide tool ofthe present invention. In this embodiment, curved guide tool 610includes a handle 615, curved guide 620 and an outrigger 650. The curvedguide tool 610 is operated by a surgeon grasping handle 615. The curvedguide 620 is positioned within a throughbore 631 in handle 615, suchthat a portion 628 of the guide 620 is proximal to the handle 615 and aportion 621 of the guide 620 is distal to the handle 615. A setscrew 626secures guide 620 relative to handle 615. Alternatively, setscrew 626may instead be a movable screw such that the screw may be loosened andguide 620 can move in the distal-proximal direction relative to handle615 or rotate on an axis of a linear portion (generally, 621, 628) ofguide 620 relative to handle 615.

The guide 620 includes a curved distal end 622 and may include a flange629. Flange 629 is either integrally formed with the distal end 622 oris connected to the distal end 622 at connection site 625. The flangemay have an offset from a longitudinal axis of the curved guide. Theoffset may further be at any angle, such as between about 0 and about 90degrees, and more particularly at about 90 degrees. The flange mayfurther include a second offset, positioned distal to the first offset.This offset, may be 0 degrees, more than 0 degrees, at least 20 degrees,at least 45 degrees, and most particularly about 45 degrees. The secondoffset may be in a different plane than the first offset, for example itmay be in a plane that is orthogonal to that of the first offset.Additional examples of flanges within the scope of this invention areillustrated in FIGS. 20, 21A-E and 22. Flange 629 may also have asurface 624 which is generally adapted to index from soft or hard tissuewithin or near the joint, perhaps by engaging the tissue and perhapseven mating with a surface of the tissue. For example, the surface 624may engage a portion of a lateral condyle on a femur in a knee joint(see FIG. 27). In one embodiment, the surface 624 may have a shape thatmatches in some manner with the shape of the tissue, for example, theshape of a condyle. Thus, as in the various FIGS. 12-17, 20-22, and 27),flange may have a complex geometric shape, to match the correspondinganatomy of the condyle. It is also envisioned that other shaped flangesmay be used depending on the certain anatomy involved in a surgicalprocedure at a specific location in the patient.

The guide 620 is hollow, and preferably cannulated along its entirelength, to provide for the passage of, for example, a flexible drill pinor guide wire, therethrough. The outrigger 650 may include a swivelconnection 654, connecting outrigger main body 651 to handle 615. Themain body 651 may include an opening 652. Outrigger 650 also includes anextension 653, having a longitudinal axis along its length. As seen inFIGS. 12, 14, and 15, with curved guide 620 secured to handle 615through setscrew 626, for example, outrigger 650 may swivel atconnection 654 at least from the body of the handle 615 around to thebody of the curved guide 620, where guide 620 may nest within opening652 at a maximum range of outrigger 650 motion towards guide 620.Outrigger 650, throughout its swivel range, remains along the generalplane of the guide tool 610, wherein the plane is defined generallyalong the longitudinal axes of all of handle 615, guide 620, andoutrigger 650. Opening 652 in main body 651 also allows outrigger 650 topass over the portion 628 of curved guide 620. In the embodiment ofcurved guide 620 connected to handle 615 through a movable screw, curvedguide 620 is positioned sufficiently in the distal direction, relativeto handle 615, to shorten the length of portion 628 to allow passagethrough opening 652. The movable screw may be loosened to adjust thedistal-proximal arrangement of curved guide 620 relative to handle 615.Once outrigger 650 moves over portion 628, surgeon may then readjust thedistal-proximal arrangement of curved guide 620 relative to handle 615as needed.

In an alternative embodiment, a curved guide tool 710 includes a flange729 having a complex three-dimensional shape along its surface 724. Thethree-dimensional shape is intended to provide added stability to theconnection between the curved guide tool 710 and specific tissue at thesurgical site. The complex three-dimensional shape may include at leastone curve 766 and a degree of tilt 769. The flange 729 may either beintegral with a distal tip 722 of the guide tool 710 or may be removablysecured to the distal tip at connection site 725. The flange 729 mayfurther be offset (see FIGS. 42 b, 42 c) from a general plane of thecurved guide tool 710, the plane being defined by the longitudinal axesof the portion 721, the curved distal tip 722 and the handle 715. Theflange 729 may be offset towards one side of this plane, which mayprovide for increased engagement of the flange to the tissue or anatomyat the surgical site.

Flange 729, extending from the distal tip 722, has a complexthree-dimensional shape along substantially its entire length, which maysubstantially mimic along surface 724 the anatomical features of thesurgical site for its intended use, which may provide a stableconnection between the guide, and related instrumentation, and thesurgical site. To continue the exemplary use for an ACL reconstruction,the flange 729 may be shaped to engage a distal femur on a condyle, anedge of a condyle, adjacent to a condyle, or a combination of any ofthese. FIGS. 38-42 illustrate this flange and relative engagement to adistal femur. As specifically illustrated in FIGS. 40 and 41, forexample, the flange 729 is right-hand oriented to engage the anatomy ofthe right-hand condyle. The complex three-dimensional shape may providefor an even greater ability of the flange to substantially mimic theanatomy, such as a condyle in the knee, as the flange may includemultiple three-dimensional shapes, as will be described below.

The flange 729 may include a first curve 766 in a generally up-downorientation. Thus, as illustrated, the flange 729 extends in a shapewhich may have a curve, making the flange generally concave such that aportion of the anatomy nests within the curvature of the flange. Thisfirst curve may extend along at least a portion of the length of theflange, or, alternatively, substantially the entire length of theflange. The exact length of the curve, as well as the angle of curve, isdependent on the anatomical structure at the surgical site of theintended use of the specific flange 729 and tool 710. For example, asillustrated in FIGS. 38-42, this first curve 766 may be between about 0degrees and about 90 degrees, and more specifically, between about 30degrees and about 60 degrees, and more specifically about 45 degrees.

Also, at least a portion of this flange 729 may additionally have adegree of tilt 769 such that at least a portion of the flange may betilted or rotated to one side, relative to the general plane of thecurved guide tool 710, the plane being defined by the longitudinal axesof the portion 721, the curved distal tip 722 and the handle 715. Thetilt may allow the flange shape to better accommodate the anatomy, suchas a condyle. The tilt of at least a portion of the flange may bebetween about 0 degrees and about 90 degrees, though, as illustrated, inthis embodiment the tilt is about 45 degrees relative to the plane.Additionally, also as illustrated, the tilt may be applied tosubstantially the entire flange 729.

This embodiment of the flange may also include a second curve 767 in asideways direction, relative to the first curve, which may provide forbetter engagement of the anatomy by following the curvature of the edgeof the condyle, for example. Thus, in this flange 729, which isillustrated as a right-hand flange, at least a portion of the flange maycurve generally to the right side, though such a sideways curve maycurve in multiple directions to form more complex curves such as, forexample, a shape similar to an “S”-curve, or the like. The right-handcurve, as illustrated, may have a shape which follows the edge of thecondyle and provide for a stable attachment whereby the flange engagesthe edge of the condyle along a substantial portion of its length. Ofcourse, for a left-handed guide, at least a portion of the flange wouldcurve to the left-hand side. This second curve may be only on a portionof the flange or along substantially the entire length. The angle ofthis curve may be between about 0 degrees and about 90 degrees, and mayspecifically have an angle which may generally mimic the anatomy. Asillustrated, for example, the second curve 767 on flange 729 is about 15degrees.

Each of the above curvatures and tilts of the flange 729 may contributeto a complex three-dimensional shape of the flange and each may assistin providing a more stable connection between the anatomy and the guide710 by more closely mimicking the anatomy. The flange may furtherproject in a direction generally transverse to the distal tip of theguide, as well as a flexible drill pin extending from the distal tip ofthe curved guide. Having the flange extend in this generally transversedirection may, once again, provide for a better engagement of the guideto the anatomy. Continuing this example, the flange should stably engagethe anatomy adjacent to the edge of the condyle in the distal femur ator close to the natural ACL attachment site to the femur. The anatomy atthis location on the femur may be fairly wide, such that the flange, toproperly engage this anatomy, must extend in a transverse direction toproperly wrap around the edge of the condyle and allow the anatomy tonest within the curvature of the flange, while still directing thedistal tip 722 of the tool 710 towards the native attachment site of theACL, or other desired attachment site, for preparation of the bonetunnel for placement of the ACL graft.

In an alternative example, where the flange is designed for use in a PCLreconstruction surgery, the curve, curves, tilt, offset, and otherangles may be adjusted to provide for a secure engagement of the flangeto, for example, a proximal end of a tibia (for preparation of a tibialtunnel). The dimensions of the flange may also be adjusted to accountfor and to avoid the distal femur and other adjacent anatomy. Asillustrated in FIGS. 43-44, and discussed further below, a tool 810 mayapproach a tibia from a posterior aspect, and thus the curve and flange(not shown) of the tool may need to maneuver around the distal femur,with the knee at normal flexion. Thus, the flange may requirealternative curve(s), tilts and/or offset to account for such anapproach to the tibia.

The complete complex three-dimensional shape may thus include at least aportion of the flange having a first curve 766 and at least a portion ofthe flange having a degree of tilt 769. The flange may also extend in adirection transverse from the distal tip of the guide, creating anoffset positioning of the flange. The complex shape may further includea second curve 767 along at least a portion of the flange. The complexthree-dimensional shape may then be any combination of these curves andtilt, along with a degree of extension in a transverse direction fromthe distal tip, which may be required to engage a portion of anatomyalong a substantial portion of, or substantially all of, the length ofthe flange. In alternate embodiments, additional curves and/or tilts,and different offset angles and angle of transverse extension, may becombined to form any type of three-dimensional shape as is necessary tocreate a secure engagement between the tool 710 and the anatomy at thesurgical site.

In yet a further embodiment, curved guide tool 810 may include, asillustrated in FIGS. 28-33, a handle 815, cannulated guide 820 and aplug 812. The cannulated guide tool 810 may further include an outrigger850. The cannulated guide tool 810 is operated by a surgeon graspinghandle 815. The guide 820 may be hollow, having a cannulated openingpreferably along its entire length, and further through the handle 815,and to a cannula entry 825, to provide for the passage of, for example,a flexible drill pin or guide wire, therethrough.

The plug 812 may be positioned within the cannulated opening ofcannulated guide 820, the cannulated opening may pass completely throughthe entire length of the tool 810, from a distal end 828 of cannulatedguide 820 to a cannula entry 825 at a proximal end of tool 810. Asillustrated in FIG. 30, plug 812 may be positioned towards the proximalend of tool 810, and generally within handle 815, though other positionsalong the cannulated opening are envisioned.

As illustrated in FIGS. 31 and 32, plug 812 may include a dam 814 and apivot 811. Plug 812 is positioned relative to the cannulated openingsuch that dam 814 may, at a closed position, be positioned tosubstantially block the path of the cannulated opening (see FIG. 30).Dam 814 may be pivoted away from the path of the cannulated opening byrotation at pivot 811, along axis A, to an open position where thecannulated opening path is substantially clear relative to dam 814. Plug812 may include various arrangements for controlling the position of dam814. As illustrated in FIGS. 30-32, plug 812 may include a manualactivation 813, controllable by, for example, a thumb of the surgeon. Asthe plug 812 is pivoted, the manual activation 813 may travel through amanual activation groove 826 in the handle 815. Groove 826 is of asufficient size to allow the manual activation 813 a full range ofmotion sufficient to pivot dam 814 from the closed position to the openposition.

FIGS. 33A-C further illustrate this embodiment of plug 812. FIG. 33Aillustrates the dam 814 at the open position, such that the path of thecannulated opening is substantially clear. FIG. 33B illustrates therotation of dam 814 around pivot 811 as dam 814 rotates from the openposition to the closed position. FIG. 33C illustrates dam 814 at theclosed position, wherein the dam substantially blocks the path of thecannulated opening.

It is envisioned that other types of valves or dams may also be used forplug 812, such as a knife valve, which, rather than pivoting on an axis,moves along a plane, in an up and down motion, perpendicular to the pathof the cannulated opening. The surgeon may be able to manually controlthe up and down motion of the dam. Alternatively, the valve could be abutterfly valve, wherein the dam would be split into two portions, andeach portion is hinged along a central, stationary, support. Each damportion can be manually actuated or be spring loaded. Other forms ofvalves, dams or the like are also envisioned.

In another embodiment to the plug 812 illustrated in the Figures, ratherthan the manual activation, the dam 814 may be spring loaded, or thelike, such that it may be biased towards either the closed position orthe open position.

Specifically, plug 812 is intended to maintain adequate clear liquidpressure inside the joint, during arthroscopic surgery, to maintainvisibility for the surgeon by forcing blood and other debris from thejoint. Clear liquids used by surgeons in arthroscopic surgery includesaline, Ringers solution, and the like.

In use, plug 812 is intended to limit the amount of clear fluid, theflow of which is designated at “L” in FIGS. 33A-C, which exits the jointthrough the cannulated guide tool 810 through the cannulated opening andout the cannula entry 825 while still permitting the surgeon to utilizethe tool 810 to, for example, pass a surgical instrument, or the like,through the cannula entry 825 and into the cannulated opening and intothe joint. Thus, plug 812 is intended to be in the closed position whenthe surgeon has positioned the tool 810 in or adjacent the joint, but isnot prepared to utilize the tool 810 or the cannulated opening. When theplug 812 is in the closed position (FIG. 33C), the dam 814 substantiallyprevents the flow of clear liquid from the cannula entry 825. Then, whenthe surgeon is prepared to use tool 810, for example, in passing a pinthrough the cannulated opening, the dam 814 may be opened to allow thepassage of the surgical instrument. Of course, it is expected that somefluid loss may occur when using the tool 810 and when the dam 814 is inthe open position.

The dam 814 may be opened or closed by the surgeon using the manualactivation 813. Additionally, the dam 814 may pivot semi-automatically.For example, as in FIG. 33B, if dam 814 were positioned somewhere inbetween the open and closed position, the force of the clear liquid flowL passing up through the cannulated opening may contact a distal face ofthe dam 814, whereby the dam 814 is forced to the closed position, whichin turn prevents further flow of liquid out of the joint and to cannulaentry 825. Moreover, the distal face of dam 814 may include a taper 816,which may provide increased pressure on the distal face of the dam 814by the clear liquid. Taper 816 may also be useful in assisting the dam814 to pivot to the closed position when dam 814 is closer to the openposition, and possibly even when the dam 814 is substantially in theopen position. This may particularly be important in the event thesurgeon is not using tool 810, but neglected to pivot dam 814 to theclosed position manually. Of course, plug 812 may also include a springbias (not shown) towards, for example, the closed position, to preventsuch an oversight by the surgeon and ensure adequate clear liquidpressure is maintained inside the joint.

When the surgeon is ready to use the tool 810, the dam 814 may be openedmanually, using manual activation 813 or by physically pressing theinstrument against a proximal face of the dam 814, forcing dam 814 intothe open position. Pressing the instrument against the proximal face ofdam 814 may also be used when a spring bias is holding the dam 814 inthe closed position, though of course, the manual activation 813 maystill be present and used in conjunction with the spring bias.

Plug 812 also allows the surgeon to do multiple tasks at once, as theuse of plug 812 frees up a hand of the surgeon, or assistant, whoordinarily may have to, for example, place a thumb at the cannula entry825 to prevent loss of clear liquid from the joint when the surgeon isnot using tool 810. Plug 812 also allows the surgeon to use one hand tocontrol the tool 810 in that the surgeon may grip the handle and use athumb to open or close plug 812 as desired.

Any of the above exemplary instrumentation systems may further include aflexible reamer 30, 130. As illustrated in FIGS. 34A-B and 35A-C,flexible reamer 30, 130 includes a shaft 37, 137 which may include aflexible portion. The flexible portion is made by taking metal tubingand forming a laser cut in the metal to a sufficient depth to allowflexing about the cut. The laser cut may extend circumferentially aroundthe outer surface of the tubing and may have a wave or sinusoidal shapeto enhance flexibility. The flexible portion is then laser welded to atip 35, 135. In a further embodiment, the laser cuts may pass completelythrough the tubing to form discrete, interlocking portions of tubingwhich may be interlocked by the shape of the cuts, for example, likejig-saw puzzle pieces, such that shaft 37, 137 may be a single piece,and the laser cut may then be applied to the tubing to form the flexibleportion. Each jig-saw puzzle piece may be a fraction offset from thepieces above and below to improve stability and may also provide asmooth function of the reamer. At the distal end of the flexible shaft37, 137 is the tip 35, 135 which may be laser welded. The tip 35, 135may have a diameter for producing a pilot hole on the surface of thebone, and may further create the tibial and/or femoral tunnel (asdiscussed below, in some methods, the tibial tunnel may be formed usinga typical stiff-shafted reamer). The entire reamer 30, 130 may becannulated such that reamer may be positioned over the pin, such thatthe pin is within the cannulated portion, which may allow the reamer totravel along the pin and form the tibial and/or femoral tunnels. Thecannulation along the flexible portion of the flexible reamer is suchthat the reamer may travel along the bent portion of the flexible pinsuch that the reamer may follow the curved path of the flexible pin. Aproximal end of flexible reamer 30, 130 includes a drive element (notshown) which may be inserted into a standard power drill chuck. Theproximal end of reamer 30, 130 may also include a stop feature to limitthe depth of a pilot hole drilled in bone. The shaft of the reamer ofthis invention is also disclosed in co-pending patent applications, U.S.application Ser. No. 12/460,310, filed Jul. 16, 2009, by the sameassignee as this patent application, entitled “Suture AnchorImplantation Instrumentation System,” and U.S. application Ser. No.12/821,504, filed Jun. 23, 2010, by the same assignee as this patentapplication, which is a continuation-in-part of U.S. application Ser.No. 12/460,310, the disclosures of which are hereby incorporated byreference herein as if fully set forth herein.

The tip 35, 135 of reamer 30, 130 may include at least one prominentcutting edge 136, such that the tip is asymmetric. The single prominentcutting edge 136 may provide for easier entry and exit from a tunnelwhen going over a curved pin, and may further, for example, bepositioned on the femur away from cartilage or other soft tissue locatedon the condyles or surrounding femoral surface. Furthermore, the tip mayinclude additional smaller cutting edges 138. In one example, twoadditional cutting edges 138 are positioned on the tip. The tip remainsasymmetrical, but the two additional cutting edges have numerousbenefits including better continuity of the surface of the bone tunnel(less chance that a “thread pattern” results from asymmetrical drillingusing a single cutting edge), less wear on cutting edges 136 and reducedbreakage of the tip. In some embodiments, the diameter of the reamer issufficiently larger than the outer diameter of the pin such that thereamer may have sufficient strength of material surrounding thecannulation (through which the pin is positioned).

The instrumentation system may include further instruments which may beused in soft tissue repair or reconstruction, such as, for example,straight stiff-shafted reamers, various types of suture, suturegraspers, pin graspers, and the like.

The present invention also includes various surgical methods using theabove-discussed instrumentation system for repair or reconstruction ofsoft tissue. As above, the exemplary surgical site will be for thepreparation of bone tunnels for the repair and/or reconstruction of adamaged ACL. For all embodiments, a flexible pin constructed of Nitinol,or the like, may be used as such material may bend prior to passing intothe femur and may still form a generally straight and substantiallylinear tunnel path through the femur.

In a first embodiment, the method of ACL reconstruction may includeforming a tibial tunnel through the tibia. The tibial tunnel may haveany depth suitable to the surgery, soft tissue graft size, or the like.In one example, the diameter of the tunnel may be about 8-10 mm, thoughother sizes may be suitable as well. The tunnel may be directed in aproximal direction through the tibial plateau and may open into the kneejoint. The tunnel may be formed using a drill (stiff or flexible shaft),reamer or the flexible reamer. The drill may then be removed from thetibia and a flexible pin may be passed up through the tibia. The pinshould be passed through the tibia until a distal portion extends intothe knee joint. An anterior-medial portal may also be formed through theskin to allow access into the knee joint. Typically, the anterior-medialportal will pass directly through the skin and into the joint, withoutpassing through bone. A femoral aimer may be passed through the portaland positioned within the knee joint. As the distal portion of the pinenters the joint (such that, for example, about 10-20 mm of the distalportion of the pin is exposed within the joint), the femoral aimer mayinteract with the pin to engage the distal portion of the pin and adjustthe trajectory of the pin to bend and guide it towards a desiredlocation on the femur.

Optionally, the desired location on the femur may be marked using astarter awl, or other instrument, to form a pilot divot. Various methodsof using the starter awl may be used. One example would be to use thefemoral aimer to determine the proper location for the femoral tunnel toensure the tunnel will have a sufficient “back wall” (i.e., theposterior side of the femur) Then, a standard drill (i.e., 2.4 mm)penetrates the femur at the desired location to a depth of a fewmillimeters. The drill is then removed and the awl is used to widen thetap to about 3 mm. A second exemplary use of the awl would be to use theawl freehand and judge, using visual cues and experience, the back walldistance and proper location of the femoral tunnel. A third exemplaryuse of the awl would be to use a microfracture pick, or the like,freehand and judge, using visual cues and experience, the back walldistance and proper location of the femoral tunnel. Then, themicrofracture pick should be removed and the awl is used to widen thetap to about 3 mm.

Once the pin is placed against the femur (whether or not the awl wasused to create a pilot divot), the pin may be passed through the femuruntil it exits the femur, proximal to the knee joint, and through theadjacent skin. For example, the pin may be attached to an electric drilland drilled into the femur to a depth of about 20 mm, at which time theaimer may be released from the pin, if possible. The pin is then drilledcompletely through the femur and out through the skin.

A flexible reamer (which may, for example, be cannulated) may then bepositioned onto the pin such that the flexible reamer passes through thetibial tunnel and contacts the femur. The reamer may then be used toform a femoral tunnel to a specified depth, for example, about 30 mm,though as with all dimensions disclosed as to these methods, the depthmay be dependent on the specific surgery and may thus be greater or lessthan 30 mm or may be sufficient for penetrating through the entire femuralong the path of the pin. Leaving the pin in place, the reamer may thenbe removed from the femur and tibia. The pin may have a suture connectoron its proximal portion (i.e., an eyelet or the like), through which asuture may be passed which may contain a soft tissue graft thereon. Thepin is then pulled proximally, from where it exited the femur, to pullthe suture and graft up through the tibial tunnel and into the femoraltunnel. The graft may then be secured.

In another embodiment, the method may include forming a tibial tunnelthrough the tibia, in any way known in the art. In one example, thediameter of the tunnel may be about 8-10 mm, though other sizes may besuitable as well. The tunnel may be directed in a proximal directionthrough the tibial plateau and may open into the knee joint. The tunnelmay be formed using a drill. In alternate embodiments, the femoraltunnel (discussed below) may be reamed first, followed by the tibialtunnel.

The drill may then be removed from the tibia and a flexible pin may bepassed up through the tibia. The pin should be passed through the tibiauntil a distal portion extends into the knee joint. An anterior-medialportal may also be formed through the skin to allow access into the kneejoint. A femoral aimer may be passed through the portal and positionedwithin the knee joint. As the distal portion of the pin enters thejoint, the femoral aimer may interact with the pin to adjust thetrajectory of the pin and guide it towards a desired location on thefemur. Optionally, the desired location on the femur may be marked usinga starter awl, or other instrument, to form a pilot divot. Once the pinis placed against the femur, the pin may be passed through the femuruntil it exits out the femur, proximal to the knee joint, and throughthe adjacent skin. As above, the pin may be drilled into the femur, andthe aimer, if possible, releases the pin once it is about 20 mm into thefemur. The pin may have a suture connector on its proximal portion(i.e., an eyelet or the like), through which a suture is passed. The pinis then pulled proximally, from where it exited the femur, to pull thesuture up through the tibial tunnel and into the joint space.

The suture and/or proximal portion of the pin may then be grasped by aninstrument through the anterior-medial portal, and the pin may then bepulled backwards through the portal. A flexible reamer (which may, forexample, be cannulated) may then be positioned onto the pin such thatthe flexible reamer passes through the portal and contacts the femur.The reamer may then be used to form a femoral tunnel to a specifieddepth (as above, about 30 mm, depending on the specifics of the surgicalsite). Leaving the pin in place, the reamer may then be removed from thefemur and the portal. The pin may then be loaded with a free suture(through the suture connector) and pulled, from its distal end, back upthrough the femoral tunnel, until the proximal end, and attached suture,of the pin is visible within the knee joint. The attached suture may begrasped by an instrument, through the tibial tunnel, and the pin maythen be moved distally back through the tibial tunnel, such that thesuture and suture connector are outside the tibia on the distal end ofthe tibial tunnel. A suture, containing a graft, may be placed on thesuture connector. The pin is then pulled proximally, from where the pinexited the femur, to pull the suture and graft up through the tibialtunnel and into the femoral tunnel. The soft tissue graft may then besecured by any means known in the art.

Alternatively, when reaming the femur through the anterior-medialportal, rather than first passing the flexible pin through the tibia,the pin may be immediately passed through the portal and positioned ontothe femur, and stabilized, using the femoral aimer. The pin may then bedrilled into the femur, as discussed above, followed by the use of thereamer to form the femoral tunnel, as above. The tibial tunnel maysubsequently be prepared, and the graft may then be brought into placeas above.

In yet another embodiment, the method may include passing a flexible pinthrough the tibia. The pin may be directed in a proximal directionthrough the tibial plateau and into the knee joint. Alternatively, theinitial insertion of the pin may be done by drilling a rigid pin throughthe tibia and into the joint which may then be removed and replaced witha flexible pin. However, using the flexible pin even for the initialpreparation of the tibial tunnel offers possible advantages in reducingthe time required to drill the two tunnels. An anterior-medial portalmay also be formed through the skin to allow access into the knee joint.A femoral aimer may be passed through the portal and positioned withinthe knee joint. As the distal portion of the pin enters the joint (about15 to about 20 mm), the femoral aimer may interact with the pin toadjust the trajectory of the pin and guide it towards a desired locationon the femur. Optionally, the desired location on the femur may bemarked using a starter awl, or other instrument, to form a pilot divot.Once the pin is placed against the femur, the pin may be passed throughthe femur until it exits the femur, proximal to the knee joint, andthrough the adjacent skin. As in the above embodiments, the pin may bedrilled into the femur, and once about 20 mm of the pin is within thefemur, the aimer may release the pin, if possible.

A flexible reamer (which may, for example, be cannulated) may then bepositioned onto the pin such that the flexible reamer follows the pathof the pin and drills through the tibia and the femur in a singlecontinuous motion to form a tibial tunnel and a femoral tunnel. Thereamer diameter may be, for example, about 8-10 mm. The reamer may forma femoral tunnel to a specified depth. Leaving the pin in place, thereamer may then be removed from the femur and tibia. The pin may have asuture connector on its proximal portion (i.e., an eyelet or the like),through which a suture is passed which may contain a graft thereon. Thepin is then pulled proximally, from where it exited the femur, to pullthe suture and graft up through the tibial tunnel and into the femoraltunnel. The graft may then be secured.

In another embodiment, the method may include forming a tibial tunnelthrough the tibia. The tunnel may be directed in a proximal directionthrough the tibial plateau and may open into the knee joint. The tunnelmay be formed using a drill with a diameter (i.e., about 5 mm) which isnarrower than the diameter of the final tibial tunnel (i.e., about 8-10mm), discussed below. The narrow-diameter drill may then be removed fromthe tibia and a flexible pin may be passed up through the tibia. The pinshould be passed through the tibia until a distal portion extends intothe knee joint. An anterior-medial portal may also be formed through theskin to allow access into the knee joint. A femoral aimer may be passedthrough the portal and positioned within the knee joint. As the distalportion of the pin enters the joint, to a depth of for example, about10-20 mm, the femoral aimer may interact with the pin to adjust thetrajectory of the pin and guide it towards a desired location on thefemur. Of course, movement of the pin in the proximal/distal directionmay be required, in coordination with the movement of the aimer, toproperly align the pin with the femur. Optionally, the desired locationon the femur may be marked using a starter awl, or other instrument, toform a pilot divot. Once the pin is placed against the femur, the pinmay be passed through the femur until it exits the femur, proximal tothe knee joint, and through the adjacent skin. As discussed in otherembodiments of the method, the pin may be drilled to a depth of about 20mm into the femur, at which point the aimer may release the pin. The pinis then drilled completely through the femur and skin.

A flexible reamer (which may, for example, be cannulated), having thelarger diameter than the narrow-diameter drill, may then be positionedonto the pin such that the flexible reamer expands the diameter of thetibial tunnel and contacts the femur. This embodiment may allow theflexible pin to be more easily maneuvered through the initial smalltibial drill hole compared to when the flexible pin was drilled directlythrough the tibia in an above embodiment. Moreover, the flexible reamermay have an easier time transitioning from the tibial tunnel to thefemoral tunnel when compared to an embodiment where the tibial tunnel isdrilled to its final diameter in a single pass. The reamer may then beused to form a femoral tunnel to a specified depth (i.e., about 30 mm).Leaving the pin in place, the reamer may then be removed from the femurand tibia. The pin may have a suture connector on its proximal portion(i.e., an eyelet or the like), through which a suture is passed whichmay contain a graft thereon. The pin is then pulled proximally, fromwhere it exited the femur, to pull the suture and graft up through thetibial tunnel and into the femoral tunnel. The graft may then besecured.

In another embodiment, the instrumentation system may be used in amethod of “all-inside” ACL reconstruction. In this method, both thetibial and femoral tunnels are prepared from portals. For example, thefemoral tunnel may be prepared using the method above where the tunnelis reamed directly through the anterior-medial portal. The tibial tunnelis likewise prepared through such a portal. First, a flexible pin isinserted through a superior portal and an aimer is inserted through ananterior portal (either medial or lateral). The pin may be directed tothe tibial insertion site, and the aimer may bend the pin at theinsertion site such that the pin is positioned towards the anteriorsurface of the tibia. The pin is then passed through the tibia (using adrill or the like), exiting out the anterior of the tibia. A flexiblereamer (having a diameter of for example 8-10 mm) is then positioned onthe pin and passes through the tibia to an appropriate depth from theinterior of the joint (i.e., starting at the tibial plateau) andextending distally into the tibia. The pin, which may include a sutureconnector, is then used to guide a graft into the femoral and tibialtunnels, through the portal, and the graft is secured.

The present invention may also be used in soft tissue repair orreconstruction of other soft tissues in the body. For example, asillustrated in FIGS. 36A-C, the instrumentation system may be used torepair or reconstruction the Posterior Cruciate Ligament (PCL). In thismethod, a posterior (medial or lateral) portal may be created throughthe skin and into the knee joint, through which a flexible pin may bepassed. An aimer may be directed through an anterior (medial or lateral)portal and into the knee joint as well. The aimer interacts with the pinand adjusts the trajectory of the pin from its position exiting thefemur to contact the posterior portion of the tibia, and towards thedirection of the anterior portion of the tibia. The pin may then bepassed through the tibia, by use of a drill for example, from the entryposition on the posterior of the tibia to an exit location on theanterior portion of the tibia. A flexible reamer may then be placed overthe pin to form the tunnels having a diameter of, for example, about8-10 mm, until it passes completely through the tibia. Finally, usingtechniques known in the art, a graft may be placed within the tunnelsand secured.

In another embodiment for soft tissue reconstruction, specifically as tothe PCL, the tibial tunnel can be drilled from the posterior aspectanteriorally using the instrumentation system, such as for example, tool810 as illustrated in FIGS. 43 and 44. Typical PCL tibial tunneldrilling is normally attempted from the anterior aspect to the posterioraspect, which poses a great risk to critical structures (e.g., poplitealvessels). Using the various instruments discussed above, such as thosein FIG. 5-9 or 10-17, the flexible pin can be directed from a posteriorportal, through the skin, to the tibial PCL insertion site and drilledto exit out the anterior surface of the tibia (FIGS. 43-44). A flexiblereamer could be inserted over this flexible pin to ream a tunnel.

Following placement of the pin using tool 810 as in FIGS. 43 and 44, forexample, the reamer could then be placed over the pin from either theanterior side of the tibia or from the posterior side of the tibia tocreate the tibial tunnel since the pin may extend completely through thetibia and protrude from both the anterior and posterior exit sites.Typically, tool 810 would be removed from the surgical site once theflexible pin is in place. For example, if the surgeon feeds the reameronto the tip of the flexible pin, exiting the anterior of the tibia, thesurgeon may then ream in the posterior direction. While this directionof drilling the tunnel, generally speaking, is well known in the art,the use of the flexible pin, and thus a curved pathway of the pinbetween the tibia and femur, may provide for a decreased risk ofplunging the reamer deep into the posterior aspect of the knee, which,traditionally, has caused complications in procedure in which a straightrigid pin was used.

FIGS. 37A-E illustrate yet another embodiment of a method of using theinstrumentation system. The main difference as compared to the abovemethods is illustrated in FIGS. 37B-E in which the flexible reamerpasses along a heavy suture through the tibial tunnel and engages theflexible pin once within the joint.

Alternative methods of preparation of the femoral tunnel may alsoinclude the curved guide tool 510, 610, 810. The curved guide tool maybe used, for example, in place of the femoral aimer to bend the flexibledrill pin towards the proper location on the femur.

The curved guide tool 510, 610 may be used, in one embodiment, in amethod of ACL reconstruction. Specifically, the tool 510, 610 may beused to prepare the femur for reattachment of the torn ACL, attachmentof a replacement graft ACL, or any similar procedure. In an exemplaryembodiment, the preparation of the femur may include creating agenerally straight and substantially linear tunnel in the femur at thedesired site on the femur for subsequent attachment of the ACL graftwithin the tunnel.

In one embodiment of ACL reconstruction using tool 510 (tool 610 maylikewise be used, though for simplicity of illustration, tool 510 willbe the exemplary instrument of this embodiment), an anterior-medialportal (not shown) is created in the tissue surrounding the knee joint,as is known in the art. A surgeon, as illustrated in FIGS. 23-25, forexample, using the tool 510, holding the handle 515, may position thedistal end 522 of the hollow curved guide 520 through theanterior-medial portal, and the distal tip 523 of the curved guide maybe positioned on the femur surface. The distal tip 523 is pointed andmay engage the femur to secure the distal end 522 at the desiredposition on the femur, in this case, the point of attachment of the ACLgraft. Alternatively, distal tip 523 may be used as a starter awl tomark the desired attachment point. Once the desired attachment point isdetermined and the distal end 522 is secured to the femur, the outrigger550 is swiveled away from the handle 515 and rotated towards the portion521 of curved guide 520 and towards the outer skin surface of thepatient (not shown). The outrigger 550 is swiveled until the extension553 comes to rest on the outer skin surface of the patient, or into thesurgical wound bed if the knee has been opened in that area or openeddue to injury, for example. The ability of the outrigger to accuratelydesignate the path of movement of the drill pin through the bone, whiletypically remaining on the outer surface of the skin, allows for a lessinvasive surgical procedure. This resting position may be at any pointup to and including where the portion 521 of curved guide 520 ispositioned within opening 552 of outrigger 550. It should also beunderstood that opening 552 prevents the outrigger main body 551 fromcontacting the portion 528 of curved guide 520.

Outrigger main body 551 may include a bend 555. Bend 555 may be appliedto main body 551 for various reasons such as to provide a corner inwhich the surgeon may position a finger to easily swivel outrigger, orto allow outrigger 550 additional swivel movement towards curved guide520 such that an angle between an axis of the curved guide, along itslength, and an axis of the outrigger, along its length, is less than ifthe bend 555, and opening 552, were not present.

With outrigger 550 and distal tip 523 in place, a pin, or the like, maybe passed up through the hollow curved guide 520 and passed into thefemur using any known means, such as a power drill, mallet, or the like.The longitudinal axis of outrigger 553 may be generally within a planeof the handle 515 and curved guide 520. And, since outrigger is in thesame plane as handle 515 and curved guide 520, the distal tip 523 ofcurved guide and the outrigger extension 553 should be in generally thesame plane as well. As such, the outrigger extension 553 may provide aline of sight for the surgeon to orient himself as to where the pin willexit from the side of the femur and the surrounding skin. The line ofsight allows the surgeon to locate the exiting portion of the pinquickly, and perform any necessary preparation of the surrounding skinprior to the pin passing through the skin and possibly creatingunnecessary damage, such as excessive tearing of the skin, for example.The surgeon may direct the curved guide tool 510 into the joint at anyangle, depending on the orientation of the handle 515 relative to thefemur and tibia. Thus, the line of sight laid out by extension 553 maynot be directly over the midline of the knee and femur but may insteadbe medial or lateral of this midline. Alternatively, it is recognizedthat if the tool 510 includes a movable screw rather than a setscrew526, the surgeon may rotate the curved guide 520 around its axis, andthe distal end 522 will thus curve to one side or the other of theplane, then the outrigger extension 553 and distal end 522 may not be ina single plane and the line of sight may be compromised. To alleviatethis scenario, the outrigger 550 swivel connection 554 may instead bepositioned on the portion 521 or 528 of curved guide such that outrigger550 will remain in the same plane as the curved portion 522 of thecurved guide 520.

Once the pin is passed through the femur and surrounding skin, the guidetool 510 may be removed from the surgical area. Alternativeinstrumentation, such as flexible reamer 30, 130, or the like, may thenbe used to widen the tunnel in the femur, prepare the tibia, and thenthe ACL graft may be placed and secured as is known in the art.

In an alternative embodiment of the above method, curved guide tool 610may be used. The method is similar to the example discussed above withtool 510, except for the step of placement of the curved guide 620 ontothe bone, such as the femur. Guide tool 610 may include flange 629,which is not intended to dig into bone. Rather, and as illustrated inFIGS. 26 and 27, flange 629 includes surface 624 which may be generallyadapted to substantially mate with or index soft tissue or hard tissuenear the surgical site, for example, a portion of a lateral condyle onthe femur in the knee joint. For example, the surface 624 substantiallymimics the surface of a portion of the lateral condyle such that itsubstantially mates with the condyle creating a stable connection whichmay alert the surgeon that the curved guide 620 is in a proper position.More particularly, for example, the flange 629 substantially mates withthe posterior portion of the lateral condyle (FIG. 27). Of course, theshape of the flange 629 would vary depending on its use in a left kneeor a right knee. Similarly, flange 729 may be used in this method. In afurther embodiment, if tool 710 is used in this method, and the surgeonhas a plurality of tools 710, each having a flange 729 with a differentcomplex three-dimensional shape, prior to positioning the tool throughthe portal, the surgeon may select the tool having the properly shapedflange which most closely mimics the anatomy at the surgical site toprovide a stable engagement with the femur based on a visual inspectionof the femur or simply by determining which condyle, and which positionon or around the condyle, the flange should engage. The surgeon may,alternatively, trial fit various flanges to determine which provides forthe most secure engagement with the anatomy.

Furthermore, as three-dimensional modeling of surgical sites increasesin popularity, it may be possible to create a custom-built flange usingsuch modeling and imaging capabilities such that the curves, tilt and/oroffset of the flange may be adjusted to be nearly identical to theparticular anatomy on which it will be positioned.

In yet a further embodiment, tool 510 and tool 610 may be used inconjunction with one another. For example, tool 510 may be firstpositioned into the joint, and the distal tip 523 used as an awl to markthe correct placement of the pin. For this embodiment, curved guide 520of tool 510 may be solid, such that it is not hollow or cannulated. Tool510 then may be removed from the joint, and tool 610 may then beinserted such that flange 629 positions on the surrounding tissue, e.g.,distal portion of a lateral condyle on the femur, and once in properposition, and presumably aligned with the mark left by tool 510, a pinmay be passed through curved guide 620 and into the femur. In a furtheralternative, only tool 610 would be used and a flexible starter awl maybe passed through curved guide 620 to mark the correct anatomicalposition on the bone. The awl may then be removed and the pin passedinto the curved guide 620 and into the femur.

Once the flange 629 is mated with the particular portion of the condyleits shape may substantially mimic, the distal portion 622 of curvedguide 620 may be in the desired location to perform further steps, suchas the passage of a pin, for eventual attachment of the soft tissue,such as an ACL graft, as discussed in other embodiments. Of course, tool710, with flange 729, may also be used in this method.

In yet another embodiment of ACL reconstruction, using tool 810, asurgeon establishes a flow of clear liquid into the joint to increasevisibility, using a fluid pump or the like (not shown). This step isinherent in any arthroscopic surgical procedure, including any of thosedescribed above. The surgeon next may create an anterior-medial portal(not shown) in the tissue surrounding the knee joint, as is known in theart. A surgeon, for example, using the tool 810, holding the handle 830,may position distal end 828 of the cannulated guide 820 through theanterior-medial portal, and into or adjacent to the joint. The plug 812may be in the closed position during this insertion step, though it maybe in the open position as well to, for example, release any air presentin the cannulated opening. Once the tool 810 is in position, the plugmay remain in the closed position until a time where the surgeon isready to use tool 810.

With cannulated guide 820 in place, a flexible pin, or the like, may bepassed up through the cannula entry and into the cannula guide 820 andpassed into the femur using any known means, such as a power drill,mallet, or the like. Outrigger 850 may also be used to assist in guidingthe pin into a proper position, as is discussed in detail above.

Once the pin is passed into the joint, the dam 814 may be closed again,or the guide tool 810 may be removed from the surgical area altogether.Alternative instrumentation, such as a flexible reamer or the like, maythen be used to perform the surgical procedure.

In an alternative embodiment, the tool 810 may include a flange such asflange 729 and may thus have a flange with a complex three-dimensionalshape which may provide further stability for tool 810 within thesurgical site. In a further embodiment, if tool 810 is used in thismethod, and the surgeon has a plurality of tools 810, each having aflange 729 with a different complex three-dimensional shape, prior topositioning the tool through the portal, the surgeon may select the toolhaving the properly shaped flange to provide a stable engagement withthe femur based on a visual inspection of the femur or simply bydetermining which condyle, and which position on or around the condyle,the flange needs to engage. The surgeon may, alternatively, trial fitvarious flanges to determine which provides for the most secureengagement with the anatomy.

The various instrumentation of the present invention may be groupedtogether in any combination. Such instrumentation systems may include,for example, at least one flexible pin, at least one femoral aimer, atleast one curved guide tool, and at least one flexible reamer. Thesystem may further include at least one awl, suture, tissue graftpreparation instruments, and any other instrumentation which may be usedin arthroscopic surgical procedures. It should be noted that any of thebelow instrumentation system examples may include such instrumentationas suture, graft preparation instruments, and the like, as may be usedin typical orthopedic arthroscopic surgical procedures.

In yet a further system, at least one of tool 510, tool 610, tool 710and tool 810, for at least a right or left knee, may be packaged withadditional instrumentation needed for additional steps of, for example,ACL reconstruction, such as at least one flexible drill pin 10, 110,210, at least one femoral aimer 20, 120, 220, 320, 420, at least onefemoral reamer 30, 130, or any other instrumentation known in the art.

Any other combination of the instrumentation of the present inventionmay also form a system. For example, at least one flexible pin and atleast one flexible reamer may be combined as a system. Such a system mayfurther include at least one femoral aimer, or alternatively, at leastone curved guide tool. Such a system may further include at least onestarter awl or at least one non-cannulated curved guide tool which mayalso operate as a starter awl.

In another combination, one instrumentation system may include at leastone flexible pin and one of either an at least one femoral aimer or anat least one curved guide tool. Such a system may further include aflexible reamer, a starter awl, or the like.

A further exemplary instrumentation system may include a flexible reamerand one of either an at least one femoral aimer or an at least onecurved guide tool. The system may further include a flexible pin, astarter awl, or the like.

Of course, an instrumentation system may also be combinable even whereeach instrument is packaged and arranged separately. For example, aninstrumentation system including a flexible pin, flexible reamer, and atleast one of a femoral aimer and a curved guide tool, may be packagedfor a surgeon separately, meaning each instrument is sold separately andpackaged individually. Alternatively, for example, each individualinstrument may be available separately, and when a surgeon orders theinstrumentation, the specific instrumentation ordered may be groupedtogether and packaged in a tray (not shown), which is then sterilizedand sent to the surgeon. Thus, in this example, it is conceivable thatevery system of the present invention delivered to surgeons may bedifferent from one another such that each system is tailored to fit thespecific needs of the particular surgeon.

As yet another example, in one alternative of an instrumentation kit, itis envisioned that a curved guide tool may be part of a kit in which atool 610, 710 for a left knee and a tool 610, 710 for a right knee arepackaged together. Alternatively, a tool 610, 710 could be packaged as akit with detachable flanges 629, 729, detachable at connection site625,725, including at least one for the right knee and at least one forthe left knee, or various flanges for a single knee but with variousfirst and second offsets, or any combination of such. In yet a furtheralternative, at least two of tool 510, tool 610, tool 710 and tool 810may be packaged as a kit for either the left or right knee. Of course,an individual tool, for one of the right knee or left knee, could bepackaged individually, or as a system in any combination of thosediscussed above.

In another embodiment of a kit, the kit may include a plurality of tools710, each having a flange 729 having a different complexthree-dimensional shape for use with varying portions of anatomy at asurgical site. In the example of using the tool 710 for ACL surgery, thekit may include a series of tools 710 having flanges 729 which wouldaccommodate various anatomical sites such as left condyles, rightcondyles, worn condyles, positions posterior, anterior, medial orlateral to native ACL attachment sites, or the like.

A further kit may include various versions of a femoral aimer 20, 120,220, 320, 420 with which a surgeon can determine which aimer best suitsthe particular characteristics of a surgical procedure. Such a kit maybe specific to a left or a right knee. Alternatively, such a kit mayinclude at least one femoral aimer for both a right and left knee. Ofcourse, an individual aimer, for one of the right knee or left knee,could be packaged individually, or as a system in any combination ofthose discussed above.

These exemplary embodiments of various methods, instrumentation systemsand kits may be used when the knee is positioned at a “normal” flexion,for example, at ninety degrees, and a knee holder (as is known in theart) may also be used, if needed. These methods reduce the need of asurgeon to hyperflex the knee, as well as providing methods of repairingor reconstructing an ACL in a knee that cannot undergo hyperflexion.However, the curvature of the drill pin 10, 110, 210, the curved guide510, 610, 710, 810 and consequently the reamer 30, 130 may vary suchthat the instrumentation, kits and methods of the present invention maybe used on a knee, or other joint, bent at any degree of flexion.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

1. An instrument for use in preparing a femur for soft tissue repair orreconstruction, comprising: a cannulated, curved guide tool having acannulated body extending to a distal tip and a plane defined by alongitudinal axis of the cannulated body and distal tip; and a flangesecured to the distal tip and extending from the distal tip in adirection transverse from the distal tip, the flange having a firstcurve along at least a portion of the flange and a degree of tilt,relative to the plane, along at least a portion of the flange.
 2. Theinstrument of claim 1, wherein the first curve is in at least a firstdirection.
 3. The instrument of claim 2, further comprising a secondcurve in at least a second direction, different from the firstdirection, along at least a portion of the flange.
 4. The instrument ofclaim 3, wherein at least a portion of the flange includes both thefirst and second curves.
 5. The instrument of claim 3, wherein the firstand second curves extend along substantially the same portion of theflange.
 6. The instrument of claim 3, wherein the first and secondcurves extend along different portions of the flange.
 7. The instrumentof claim 3, wherein the second curve has an angle of between about 0degrees and about 30 degrees.
 8. The instrument of claim 2, wherein thefirst curve has an angle between about 0 degrees and about 90 degrees.9. The instrument of claim 1, wherein the degree of tilt is an anglebetween about 0 degrees and about 90 degrees relative to the plane. 10.The instrument of claim 9, wherein the angle of tilt is an angle ofabout 45 degrees relative to the plane.
 11. The instrument of claim 1,wherein the flange is offset towards one side of the plane.
 12. Theinstrument of claim 1, wherein the complex three-dimensional shapesubstantially mimics the anatomy of a distal portion of the femur suchthat the flange is adapted to engage the anatomy along a substantialportion of the flange.
 13. The instrument of claim 12, wherein the shapesubstantially mimics an edge of a condyle on the distal portion of thefemur.
 14. The instrument of claim 1, wherein the cannulated, curvedguide tool is adapted to accept a flexible drill pin through thecannulated body, wherein the flexible guide pin may exit out the distaltip and into bone.
 15. The instrument of claim 14, wherein the flangeextends in a direction transverse to the flexible drill pin exiting fromthe distal tip of the cannulated body.
 16. A method of preparing a bonefor reattachment of soft tissue thereto, comprising: visualizing areattachment site; selecting a guide tool from a plurality of cannulatedcurved guide tools, each of the plurality of guide tools having a distaltip that includes a flange; directing the distal tip of the selectedguide tool towards the reattachment site; and placing the flange againstthe surrounding anatomy such that the distal tip is on the reattachmentsite.
 17. The method of claim 16, wherein the flange has a complexthree-dimensional surface which substantially mimics the surroundinganatomy.
 18. The method of claim 16, further comprising a cannulatedbody, of the cannulated curved guide tool, extending to the distal tip.19. The method of claim 18, further comprising inserting a flexibledrill pin through the cannulated body such that it exits from the distaltip and projects into the reattachment site on the bone.